Events

Recall of ENTERALITE INFINITY ENTERAL FEEDING PUMP

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by MAQUET-DYNAMED INC..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    27891
  • Event Risk Class
    II
  • Event Initiated Date
    2012-10-29
  • Event Country
    Canada
  • Event Source
    HC
  • Notes / Alerts
    Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
  • Extra notes in the data
  • Reason
    The pump uses an optical sensor to detect the presence of fluid or air in the administration set which is why at the completion of a feeding it is expected that the pump will alarm as outlined above. however residual clumps from certain types of feeding preparations may be interpreted by the sensor as food remaining in the administration set causing the pump to continue to run despite the bag being empty. this situation likely occurs with home blended or prepared food as well as non-traditional additives such as fortifiers lipids proteins etc. if the sensor is obstructed by sticky solids it may cause the pump to continue running and cause an overrun failure and may potentially deliver air to the users.

Device

ENTERALITE INFINITY ENTERAL FEEDING PUMP
  • Model / Serial
    Model Catalog: INFKIT2 (Lot serial: >1000 numbers contact mfg")
  • Product Description
    ENTERALITE INFINITY FEEDING PUMPS
  • Manufacturer
    MAQUET-DYNAMED INC.

Manufacturer

MAQUET-DYNAMED INC.
  • Manufacturer Address
    MISSISSAUGA
  • Manufacturer Parent Company (2017)
    Getinge AB
  • Source
    HC